1. What is the ProteoGenix Amniotic Fluid Bacteria/Mycoplasma/Ureaplasma by Endpoint PCR test?
The ProteoGenix Amniotic Fluid Bacteria/Mycoplasma/Ureaplasma by Endpoint PCR test uses broad-spectrum PCR assay based on 16S ribosomal DNA to provide a qualitative and sensitive tool for detecting the presence of bacterial/Mycoplasma and Ureaplasma species in amniotic fluid. The ProteoGenix Amniotic Fluid Bacteria/Mycoplasma/Ureaplasma by Endpoint PCR test offers the following clinical benefits:

• Demonstrated sensitivity of 100% and specificity of 96% versus bacterial/Mycoplasma and Ureaplasma species in AF culture.

• The ability to detect the most common causative pathogens of IAI, including Mycoplasma and Ureaplasma species that have been shown to be present in 30% to 50% of IAI cases. Tests to detect these pathogens are rarely available in most clinical laboratories.

2. Has the ProteoGenix Amniotic Fluid Bacteria/Mycoplasma/Ureaplasma by Endpoint PCR test been approved for use in the U.S.?
Yes, the ProteoGenix Amniotic Fluid Bacteria/Mycoplasma/Ureaplasma by Endpoint PCR test is available via the CLIA certifendpoint ied ProteoGenix Clinical Laboratory.

3. Can results from the ProteoGenix Amniotic Fluid Bacteria/Mycoplasma/Ureaplasma by Endpoint PCR test be used for treating patients?
Yes, this information when used in conjunction with a clinician’s experience and judgment can provide additional clinically relevant information that can assist clinicians in determining the optimal patient management strategy.

4. When should the ProteoGenix Amniotic Fluid Bacteria/Mycoplasma/Ureaplasma by Endpoint PCR test be used?
The ProteoGenix Amniotic Fluid Bacteria/Mycoplasma/Ureaplasma by Endpoint PCR test should be used to detect the presence of IAI in pregnant patients with intact membranes presenting with PTL between 22 to <37 weeks gestation.

5. How accurate are the results of the ProteoGenix Amniotic Fluid Bacteria/Mycoplasma/Ureaplasma by Endpoint PCR test?
The ProteoGenix Amniotic Fluid Bacteria/Mycoplasma/Ureaplasma by Endpoint PCR test provides a qualitative and sensitive tool for detecting the presence of bacterial/Mycoplasma and Ureaplasma species in amniotic fluid. It has demonstrated sensitivity of 100% and specificity of 96% versus bacterial/Mycoplasma and Ureaplasma species AF culture.

6. How do I order the ProteoGenix Amniotic Fluid Bacteria/Mycoplasma/Ureaplasma by Endpoint PCR test?
Amniotic fluid is required for the ProteoGenix Clinical Laboratory molecular, chemistry and microbiology tests. Please refer to the amniotic fluid processing instructions for each test under specimen collection. If you are healthcare professional and would like to order the ProteoGenix panel of tests, please follow the instructions below.
a. Complete the ProteoGenix Clinical Laboratory IAI Test Requisition form.
b. When your specimens are ready for pick up call ProteoGenix at 888-429-7935 or fax the completed form to 714-429-7853.

7. What are the clinical benefits of using the ProteoGenix Amniotic Fluid Bacteria/Mycoplasma/Ureaplasma by Endpoint PCR test?
The clinical benefits of using the ProteoGenix Amniotic Fluid Bacteria/Mycoplasma/Ureaplasma by Endpoint PCR test to diagnose IAI is that IAI is an important and potentially treatable cause of premature births, neonatal sepsis, periventricular leukomalacia/cerebral palsy and maternal febrile morbidity.

8. How is the ProteoGenix Amniotic Fluid Bacteria/Mycoplasma/Ureaplasma by Endpoint PCR test better than current methods for detecting IAI?
Numerous investigators have demonstrated that 16S rDNA polymerase chain reaction (PCR) assays have significant advantages and offer superior performance as compared to culture alone for detection of microbes in amniotic fluid. The fundamental advantage of PCR for diagnosis of IAI is that PCR identifies infection by detecting unique ribosomal DNA gene sequences of pathogenic bacteria including Mycoplasma and Ureaplasma species. This means use of PCR technology and related laboratory techniques enables the detection of microbial species that may be difficult or impossible to cultivate and therefore not detectable by amniotic fluid culture.